ProjectCoRaLa II – Long-term need of Ranibizumab injections with or without early targeted peripheral laser…

Basic data

Acronym:
CoRaLa II
Title:
Long-term need of Ranibizumab injections with or without early targeted peripheral laser photocoagulation for treatment of macular edema due to central retinal vein occlusion –CoRaLa II
Duration:
24/09/2020 to 04/02/2026
Abstract / short description:
Indication: Macular edema due to central retinal vein occlusion
The primary objective is to evaluate whether or not the duration of
guideline-conform [1] periodic ranibizumab injections may be
shortened or even be successfully terminated in patient with macular
edema due to central retinal vein occlusion if early targeted
peripheral laser photocoagulation is applied in parallel.
Primary efficacy endpoint is the time to treatment success, defined
as time from randomisation until the patient is off treatment and
without (criteria-based) treatment indication for (at least) 6 months
after the last injection.
Trial design: Multi-centric, prospective, randomized, interventional, clinical trial with two parallel groups, phase IIIb
Therapy: Intravitreal injections of Ranibizumab will be applied in all patients
according to treatment guidelines [1] . The experimental group will
receive an additional targeted laser photocoagulation of the
peripheral areas of capillary non-perfusion (up to 4 laser treatments
within 1st year of the study). No further additional treatments of the
study eye will be given in any of the arms of the trial.

Involved staff

Managers

Center for Ophthalmology
Hospitals and clinical institutes, Faculty of Medicine
University Eye Hospital
Center for Ophthalmology, Hospitals and clinical institutes, Faculty of Medicine

Other staff

Center for Ophthalmology
Hospitals and clinical institutes, Faculty of Medicine

Local organizational units

University Eye Hospital
Center for Ophthalmology
Hospitals and clinical institutes, Faculty of Medicine

Funders

Leipzig, Sachsen, Germany
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